NCT03605862

Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,756 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection

Detailed description

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection

Conditions

• Enterovirus
• Rhinovirus

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide 600 mg administered orally twice daily for five days
DRUG	Placebo	Placebo administered orally twice daily for five days

Timeline

• Start date: 2018-09-11
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2018-07-30
• Last updated: 2022-04-14
• Results posted: 2022-04-14

Locations

45 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study